Senior Pharmacovigilance Reporting Associate

ICON

Sofia, Bulgaria

Job Summary:

The Senior Pharmacovigilance Reporting Associate will prepare, perform quality checks of, and submit expedited and periodic reports for all types of safety events and other medically related project information. The incumbent will serve as safety reporting and/or pharmacovigilance intelligence lead for multiple safety reporting and/or pharmacovigilance intelligence stand-alone projects, providing management/project management support as designated and in-depth expertise regarding all aspects of safety reporting.

Job Responsibilities:

Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within study specified timelines.
Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
Maintains a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
Operate in a lead capacity ensuring ownership and accountability of safety reporting activities on assigned projects.
Collect, monitor, assess, evaluate, research, and track safety reporting information.
Coordinate and perform adverse event data entry, coding, and assessment of adverse events as needed, case review, follow-up, reportability assessment, tracking of reports and regulatory reporting activities.
Review cases entered for quality, consistency, and accuracy, including review of peer reports.
Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors. Build and maintain good relationships across functional units.
Work independently to receive, triage, manage and reconcile adverse event reports, in accordance with contractual and regulatory timelines.
Work within multiple databases. Maintenance of project information and timely updates to the project databases.
Perform quality control of documents submitted to the eTMF ensuring file readiness on assigned projects for audits or inspections.
Assist in the development of departmental Standard Operating Procedures (SOPs) and Work Procedures (WPs), as needed.
Prepare for and represent the department in audits and inspections.
Support and train less experienced staff in all aspects of safety reporting and other work, as needed.
Review regulatory and pharmacovigilance intelligence to keep updated on current regulations, practices, procedures, and proposals.
Maintain medical understanding of applicable therapeutic area and disease states.
Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations.
Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects.
Participate in departmental activities aimed at improving process and efficiency.
Perform any other activities as assigned by management.